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Status:

RECRUITING

A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Relapsed or Refractory T-cell Lymphomas

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • \- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
  • i) Adult T-cell leukemia-lymphoma (ATL).
  • ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
  • iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
  • iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
  • v) ALCL, anaplastic lymphoma kinase-negative (ALK-).
  • vi) Breast implant-associated ALCL.
  • vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).
  • viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).
  • Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
  • Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
  • Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
  • Exclusion Criteria
  • Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
  • Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
  • Have a life expectancy ≤ 3 months.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    November 20 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 10 2030

    Estimated Enrollment :

    85 Patients enrolled

    Trial Details

    Trial ID

    NCT06035497

    Start Date

    November 20 2023

    End Date

    October 10 2030

    Last Update

    May 14 2025

    Active Locations (40)

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    Page 1 of 10 (40 locations)

    1

    Anjo Kosei Hospital

    Anjo-shi, Aichi-ken, Japan, 446-8602

    2

    Nagoya City University Hospital

    Nagoya, Aichi-ken, Japan, 467-8602

    3

    Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, Japan, 441-8570

    4

    Kameda General Hospital

    Kamogawa, Chiba, Japan, 296-0041